Glutamate Reducing Interventions in Schizophrenia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Percent Change in Left Hippocampal CA1 Region Cerebral Blood Volume (CBV) From Baseline to Day 14
研究概览
简要总结
Participants will be administered several doses of pomaglumetad (POMA) (low and high doses) over 14 days to individuals at clinical high risk for developing psychosis and use magnetic resonance imaging (MRI) brain imaging to determine whether these doses of POMA are affecting glutamate levels.
详细描述
A double-blind, randomized, phase 1b, multiple dose trial of 14 days of treatment with POMA (80 mg, 160 mg, 240 mg, 320 mg) in clinical high risk patients to determine which dose, if any, reduces glutamate and metabolism using MRI techniques. The GO NO-GO decision will be whether or not any dose tested in the R61 phase of the trial decreases left hippocampal CA1 region cerebral blood volume (CBV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Identity of medications will be blinded having every subject take an equal number of pills (using identical looking tables of placebo)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capacity to provide informed consent
- •Currently using a reliable form of birth control
排除标准
- •Metal implants in body or a history of metal working
- •Lifetime diagnosis of asthmatic symptoms within the past 3 years or known sensitivity to contrast agents
- •Lifetime diagnosis of renal failure/disease
- •Acute neurological, neuroendocrine, or medical disorder including renal insufficiency (CrCl<40 mL/min/1.73m2)
- •Lifetime diagnosis of hypertension or diabetes or seizure disorder
- •Acute risk for suicide and/or violence
- •Pregnant lactating
- •Current abuse of substances (alcohol, cocaine, stimulants, cannabis, opiates, sedative hypnotics)
- •Current use or anticipated need for antipsychotics or mood stabilizers (all antipsychotics, also depakote, lithium, lamotrogine, pregabalin or any med with a mechanism of action like gabapentin), probenecid, selective serotonin reuptake inhibitors, tricyclic antidepressants, and monoamine oxidase inhibitors
- •More than one previous gadolinium scan
研究组 & 干预措施
POMA 40mg BID (80mg)
Subject will take 40mg pomaglumetad methionil (POMA) twice a day for 14 days.
干预措施: Pomaglumetad methionil (Drug)
POMA 80mg BID (160 mg)
Subject will take 80 mg pomaglumetad methionil (POMA) twice a day for 14 days
干预措施: Pomaglumetad methionil (Drug)
POMA 120mg BID (240mg)
Subject will take 120 mg pomaglumetad methionil (POMA) twice a day for 14 days
干预措施: Pomaglumetad methionil (Drug)
POMA 160 mg BID (320 mg)
Subject will take 160 mg pomaglumetad methionil (POMA) twice a day for 14 days
干预措施: Pomaglumetad methionil (Drug)
结局指标
主要结局
Percent Change in Left Hippocampal CA1 Region Cerebral Blood Volume (CBV) From Baseline to Day 14
时间窗: Baseline to 14 days of POMA/placebo
Effect of POMA on left CA1 CBV as measured by percent change from baseline scan (Time 1) to Day 14 scan (Time 2)
次要结局
未报告次要终点
研究者
Scott Small
Clinical Psychiatrist
New York State Psychiatric Institute